Clinical Trials Register

Summary
EudraCT Number:	2014-000656-29
Sponsor's Protocol Code Number:	MK8259-027
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-03-05
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2014-000656-29

A.3

Full title of the trial

Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device

A.3.2

Name or abbreviated title of the trial where available

SMART

A.4.1

Sponsor's protocol code number

MK8259-027

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02155335

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MSD Belgium BVBA/SPRL
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	MSD Belgium BVBA/SPRL
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	MSD Belgium BVBA/SPRL
B.5.2	Functional name of contact point	Marian Coquel
B.5.3	Address:
B.5.3.1	Street Address	Clos du Lynx, 5, Lynx Binnenhof
B.5.3.2	Town/ city	Brussels
B.5.3.3	Post code	1200
B.5.3.4	Country	Belgium
B.5.4	Telephone number	3247656 66 99
B.5.5	Fax number	322402 56 02
B.5.6	E-mail	marian.coquel2@merck.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Simponi® (Golimumab)
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologics B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Simponi (Golimumab)
D.3.2	Product code	MK-8259
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GOLIMUMAB
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	MK-8259
D.3.9.3	Other descriptive name	Simponi
D.3.9.4	EV Substance Code	SUB25638
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal Antibody
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Simponi® (Golimumab)
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologics B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Simponi (Golimumab)
D.3.2	Product code	MK-8259
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GOLIMUMAB
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	MK-8259
D.3.9.3	Other descriptive name	Simponi
D.3.9.4	EV Substance Code	SUB25638
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal Antibody

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ulcerative Colitis

E.1.1.1

Medical condition in easily understood language

Ulcerative colitis is a chronic and incurable autoimmune inflammatory bowel disorder characterized by continuous inflammation and ulceration of the mucosa of the rectum and, variably, the colon.

E.1.1.2

Therapeutic area

Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10045365
E.1.2	Term	Ulcerative colitis
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to determine whether UC patients prefer to administer Simponi® using the SmartJect® autoinjector, using a prefilled syringe, or are undecided.

E.2.2

Secondary objectives of the trial

• Determine which of the two delivery systems subjects consider easiest to use and resulting in the least discomfort.
• Determine how patient characteristics (disease severity, age, sex, educational level) influence device preference.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Each subject must be willing and able to provide written informed consent for the trial.
2. Each subject must be 18 years of age
3. Anti-TNF naïve adults with established diagnosis of UC and moderate to severe disease activity. The patient must also meet the following criteria: Mayo score ≥ 6, including an endoscopic subscore ≥ 2; and a previous conventional therapy of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or6-mercaptopurine (6-MP) or azathioprine (AZA), unless the patient is intolerant to or have medical contraindications for such therapies (should be documented).
4. Anti-TNF experienced adults with established diagnosis of UC and moderate to severe disease activity, either not responding, partially responding or intolerant to Remicade. The patient must also meet the following criteria: Mayo score ≥ 6, including an endoscopic subscore ≥ 2; and a previous conventional therapy of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or6-mercaptopurine (6-MP) or azathioprine (AZA), unless the patient is intolerant to or have medical contraindications for such therapies (should be documented).
5. Sexually active women of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 6 months after stopping the medication.
Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation).
Each sexually active male subject with a female partner(s) of child-bearing potential must also provide written informed consent to provide information regarding any pregnancy.

E.4

Principal exclusion criteria

1. The subject previously self-injected any agent for any condition.
2. The subject has concomitant use of other biological agents
3. The subject has had active tuberculosis within 12 months prior to the first injection or has suspected latent tuberculosis as indicated by a positive tuberculin skin test within one month prior to the first administration of golimumab or a positive chest radiograph within 3 months prior the first administration of golimumab. In case of a positive tuberculin skin test and/or chest radiograph, latent tuberculosis must be determined by a pneumologist and treated prophylactically.
4. The subject has an active clinical non-tuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, Pneumocystis carinii, aspergillosis, etc.) within 6 months prior to the first injection.
5. The subject has had an active infection and/or serious infection (HIV, hepatitis, pneumonia, pyelonephritis, severe sepsis) within 6 months prior to the first golimumab injection.
6. The subject has had a live viral or bacterial vaccination within 3 months prior to the first golimumab injection or Bacillus Calmette-Guérin vaccination within 12 months prior to the first golimumab injection.
7. The subject has evidence of heart failure NYHA class 3-4
8. The subject has a history of demyelinating disease, such as multiple sclerosis or optic neuritis
9. The subject has a history of systemic lupus erythematosus
10. The subject has a history of lymphoproliferative disease, or any unknown malignancy or history of malignancy within the previous 5 years, with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence.
11. The subject has an active hepatitis B infection.
12. The subject has an allergy or hypersensitivity to golimumab or its excipients.
13. The subject is pregnant or breast feeding
14. The subject is latex sensitive
15. The subject has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
16. The subject or a family member is among the personnel of the investigational or sponsor staff directly involved with this trial.

E.5 End points

E.5.1

Primary end point(s)

The primary preference endpoint is overall device preference as determined by the Preference Questionnaire.

E.5.1.1

Timepoint(s) of evaluation of this end point

Two weeks after administration of Simponi by two delivery methods

E.5.2

Secondary end point(s)

The secondary preference endpoints are subject’s preference of device for the following aspects:
• Ease of use
• Least discomfort

E.5.2.1

Timepoint(s) of evaluation of this end point

Two weeks after administration of Simponi by two delivery methods

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Scope is to assess preference by ulcerative colitis patients on method of delivery of Simponi (Golimumab)

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

patients receive the same medicinal product in two delivery methods which order is randomized

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last contact with last subject (may be a phone contact)

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

105

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects will continue to receive Simponi® according to the prescribing information until reimbursement by the Belgian health insurance.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-03-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-10-05

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